Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Card

FDA device recall Z-1667-2011 · posted 2011-03-16 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

Esmark bandages placed in some Presource kits/modules may not have been adequately sterilized.

Action taken

The firm, Cardinal Health, sent an "URGENT: PRODUCT RECALL" letter dated January 28, 2011 to all affected consignees/customers via UPS next day air. The letter described the product, problem and action to be taken. The customers were instructed to quarantine and return the packs/modules to Cardinal Health for destruction; contact the appropriate Customer Service group listed in the letter for return instructions, and complete and return the enclosed Acknowledgment Form via fax to 847-689-9101, regardless of whether or not they have inventory. Should you have any questions, relating to this recall, please feel free to contact Cardinal Health Quality Systems, 800-292-9332.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRO

Quantity affected

4.395 modules

Distribution

Nationwide distribution.

Date initiated

2011-01-28

Date posted

2011-03-16

Date terminated

2012-09-04

Location

Park, IL